UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034630
Receipt number R000039432
Scientific Title Pilot study for the effect of indirect perineal massage using towel for the prevention of perineal laceration before vaginal delivery
Date of disclosure of the study information 2018/10/24
Last modified on 2019/05/20 16:52:48

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Basic information

Public title

Pilot study for the effect of indirect perineal massage using towel for the prevention of perineal laceration before vaginal delivery

Acronym

The effect of indirect perineal massage for the prevention of perineal laceration.

Scientific Title

Pilot study for the effect of indirect perineal massage using towel for the prevention of perineal laceration before vaginal delivery

Scientific Title:Acronym

The effect of indirect perineal massage for the prevention of perineal laceration.

Region

Japan


Condition

Condition

perineal laceration

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of indirect perineal massage for prevention of perineal laceration.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of 2nd degrees perineal laceration.

Key secondary outcomes

Continues rate of indirect perineal massage


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Pregnant women scheduled for vaginal delivery at Juntendo Hospital will be obtain to this study. Informed consent will be obtained at the midwife outpatient clinic from 35 weeks to 36 weeks gestation,and will be instructe indirect perineal massage.

(Method of indirect perineal massage: Make a towel in a roll shape, adjust the size to the extent that there is no pain when the towel adjusted to the perineum.Make the roll towels to fit the perineum at the sitting position.Shake the body to the right and left for about 5 minutes). With pregnancy 37 week 0 as the start date, pregnant women will do as they want. Regarding the evaluation on perineal massage,a questionnaire created based on "Japanese version of Opinion of women after childbirth to perineal massage during pregnancy" developed by Takeuchi et al. (2014) "will be used.
The questionnaire will be handed and recovered at postpartum.

during postpartum hospitalization Distribute and collect.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

50 years-old >

Gender

Female

Key inclusion criteria

A pregnant woman at the 35 to 36 weeks of pregnancy who will see a midwife outpatient clinic from the approval date to November 30, 2018.

Key exclusion criteria

1,Cesarean section case.
2,Pregnant women with lesions in the perineal area (varicose veins, condyloma acuminata, herpes etc.).
3,Other who judged that the research director is inappropriate as the research subject.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Emiko
Middle name
Last name Idehara

Organization

Juntendo Hospital

Division name

Department of nursing

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Email

eidehara@juntendo.ac.jp


Public contact

Name of contact person

1st name Emiko
Middle name
Last name Idehara

Organization

Juntendo Hospital

Division name

Department of nursing

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

eidehara@juntendo.ac.jp


Sponsor or person

Institute

Juntendo Hospital

Institute

Department

Personal name



Funding Source

Organization

Juntendo Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Juntendo Hospital

Address

3-1-3Hongo, Bunkyo-ku, Tokyo

Tel

03-3814-5672

Email

kenkyu5858@juntendo.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

順天堂大学医学部附属順天堂医院


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 24 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

139

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 09 Month 12 Day

Date of IRB

2018 Year 09 Month 18 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2018 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 24 Day

Last modified on

2019 Year 05 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039432


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name